Angiotech reports Vascular Wrap safe in patients with peripheral vascular disease

By Ted A. Knutson

Washington, Nov. 17 - Angiotech Pharmaceuticals announced positive interim 12-month safety results from its novel and proprietary Vascular Wrap paclitaxel-eluting mesh trial presented at the VEITH symposium in New York.

This European first-in-man pilot study is designed to evaluate the safety of a novel and proprietary drug-loaded Vascular Wrap in the prevention of stenosis after peripheral bypass surgery.

The single-blind study enrolled a total of 109 patients at nine clinical centers in Europe as well as the Dutch Antilles and randomized patients with peripheral vascular disease in a 2:1 fashion. The treatment arm enrolled patients with a synthetic bypass graft plus the Vascular Wrap paclitaxel-eluting mesh and the control arm enrolled patients with a synthetic bypass graft alone. The primary endpoint of the study was safety.

The assessment at 12 months indicated that the Vascular Wrap was safe in this high-risk patient population, Angiotech said in a news release. Patients will continue to be monitored at 18 months and 24 months to ensure safety of the product.

"These data show that the Vascular Wrap product is safe at 12 months in very challenging patients with peripheral artery disease," said Dr. Rui L. Avelar, senior vice president of medical affairs and communications at Angiotech, in a company news release. "With the support of this safety data, we look forward to initiating our upcoming pivotal clinical trial, which will deploy our Vascular Wrap and our newly acquired Lifespan ePTFE vascular graft product line in the first ever application of our pioneering paclitaxel technology to treat restenosis in vascular surgery."

The Vascular Wrap is applied to the anastomosis site of a synthetic bypass graft and delivers the drug to the blood vessel wall in a targeted manner to prevent or reduce the stenosis (narrowing of the blood vessel) that typically follows this type of surgery.

If successful, the Vascular Wrap could potentially be used in peripheral graft procedures to prolong the life of grafts and expand the possible application into other high demand indications with no real solutions, such as AV anastomosis used for dialysis.

Peripheral arterial disease, or PAD, is a common problem in the United States with more than 20 million Americans suffering from poor blood flow to the legs.

Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty pharmaceutical company combining pharmaceutical compounds with medical devices and biomaterials to both create solutions for poorly addressed disease states and improve surgical outcomes.

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